Radioembolization and Ipilimumab in Treating Patients With Uveal Melanoma With Liver Metastases
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|ClinicalTrials.gov Identifier: NCT01730157|
Recruitment Status : Terminated (Research Cancelled)
First Posted : November 21, 2012
Last Update Posted : March 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ciliary Body and Choroid Melanoma, Medium/Large Size Ciliary Body and Choroid Melanoma, Small Size Extraocular Extension Melanoma Iris Melanoma Liver Metastases Metastatic Intraocular Melanoma Recurrent Intraocular Melanoma Stage IV Intraocular Melanoma||Biological: ipilimumab Radiation: yttrium Y 90 glass microspheres Other: laboratory biomarker analysis||Early Phase 1|
I. To estimate the safety and efficacy of sequential hepatic radioembolization and systemic ipilimumab in patients with uveal melanoma metastatic to liver.
I. To evaluate effects on regulators of tumor immunity.
Patients undergo radioembolization with yttrium Y 90 glass microspheres via hepatic arterial infusion on day 1. Beginning on day 29, patients also receive ipilimumab intravenously (IV) over 90 minutes. Treatment with ipilimumab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Sequential Hepatic Radioembolization and Systemic Ipilimumab in Patients With Uveal Melanoma Metastatic to Liver|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Treatment (yttrium Y 90 glass microspheres, ipilimumab)
Patients undergo radioembolization with yttrium Y 90 glass microspheres via hepatic arterial infusion on day 1. Beginning on day 29, patients also receive ipilimumab IV over 90 minutes. Treatment with ipilimumab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Radiation: yttrium Y 90 glass microspheres
Given via hepatic arterial infusion
Other Name: TheraSphere
Other: laboratory biomarker analysis
- Number of patients that experience grade 3-4 toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 3 weeks after discontinuation of study treatment ]
- Number of patients with an overall response of liver metastasis according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ]Sequential hepatic radioembolization and systemic ipilimumab will be considered potentially efficacious if >3/12 patients achieve objective responses because the upper limit of the corresponding exact 95% confidence interval will be >57%. The best overall response of liver metastases, from the start of hepatic radioembolization will be used for the efficacy analysis.
- Overall survival [ Time Frame: From the hepatic radioembolization procedure until death, assessed up to 5 years ]Number of patients still alive after 5 years.
- Progression-free (PFS) survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From the hepatic radioembolization to confirmation of progression or death, assessed up to 5 years ]Number of patients progression free survival at 5 years. Hepatic and extrahepatic PFS will be evaluated separately.
- Tumor genotype/phenotype Biomarkers [ Time Frame: pre-treatment (Day 0 and 28), post-hepatic radioembolization (Day 71), post ipilimumab (Year 5) ]A number of correlative studies will be performed. Data will be analyzed longitudinally using methods such as repeated measures ANOVA; however, the primary analyses will be at specific time points (e.g., pre-treatment, post-hepatic radioembolization, post ipilimumab), and these analyses will be conducted using primarily non-parametric methods (e.g., Wilcoxon signed-rank or rank sum test). All tests will be two sided with a significance level of .05, and no adjustment for multiple comparisons will be made due to the exploratory nature of these studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730157
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Michael McNamara, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|